Artículos (Medicina)

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The methodology of surveillance for antimicrobial resistance and healthcare-associated infections in Europe (SUSPIRE): a systematic review of publicly available information
(Elsevier, 2017-07-24) Núñez Núñez, María; Navarro, M.D.; Palomo, Virginia; Rajendran, NB; Toro López, María Dolores del; Voss, Andreas; Sharland, M.; Sifakis, Frangiscos G.; Rodríguez-Baño, Jesús; Medicina; European Federation of Pharmaceutical Industries and Association (EFPIA); European Regional Development Fund (ERDF); European Union (UE). FP7
Objectives: Surveillance is a key component of any control strategy for healthcare-associated infections (HAIs) and antimicrobial resistance (AMR), and public availability of methodologic aspects is crucial for the interpretation of the data. We sought to systematically review publicly available information for HAIs and/or AMR surveillance systems organized by public institutions or scientific societies in European countries. Methods: A systematic review of scientific and grey literature following the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines was performed. Information on HAIs and/or AMR surveillance systems published until 31 October 2016 were included. Results: A total of 112 surveillance systems were detected; 56 from 20 countries were finally included. Most exclusions were due to lack of publicly available information. Regarding AMR, the most frequent indicator was the proportion of resistant isolates (27 of 34 providing information, 79.42%); only 18 (52.9%) included incidence rates; the data were only laboratory based in 33 (78.5%) of the 42 providing this information. Regarding HAIs in intensive care units, all 22 of the systems providing data included central line–associated bloodstream infections, and 19 (86.3%) included ventilator-associated pneumonia and catheter-associated urinary tract infections; incidence density was the most frequent indicator. Regarding surgical site infections, the most frequent procedures included were hip prosthesis, colon surgery and caesarean section (21/22, 95.5%). Conclusions: Publicly available information about the methods and indicators of the surveillance system is frequently lacking. Despite the efforts of European Centre for Disease Control and Prevention (ECDC) and other organizations, wide heterogeneity in procedures and indicators still exists.
Metrics for quantifying antibiotic use in the hospital setting: results from a systematic review and international multidisciplinary consensus procedure
(Oxford University Press, 2018-06-06) Stanić Benić, Mirjana; Milanič, Romina; Monnier, Annelie A.; Gyssens, Inge C.; Adriaenssens, Niels; Versporten, Ann; Rodríguez-Baño, Jesús; DRIVE-AB WP1 group; Medicina; European Federation of Pharmaceutical Industries and Associations (EFPIA); European Union (UE); Innovative Medicines Initiative (IMI) Joint Undertaking
Background: Quantifying antibiotic use is an essential element of antibiotic stewardship since it allows comparison between different settings and time windows, and measurement of the impact of interventions. However, quantity metrics (QMs) and methods have not been standardized. Objectives: To propose a set of QMs for antibiotic use in inpatients (IQMs) that are accepted globally by professionals in a range of disciplines. The study was conducted within the Driving Reinvestment in Research and Development and Responsible Antibiotic Use (DRIVE-AB) project. Methods: A systematic literature review using MEDLINE identified articles on measuring inpatient antibiotic use, published up to 29 January 2015. A consensually selected list of national and international web sites was screened for additional IQMs. IQMs were classified according to the type of numerator used and presented to a multidisciplinary panel of stakeholders. A RAND-modified Delphi consensus procedure, which consisted of two online questionnaires and a face-to-face meeting, was performed. Results: The systematic literature review and web site search identified 168 eligible articles from which an initial list of 20 IQMs, composed of 20 different numerators and associated denominators was developed. The consensus procedure resulted in a final set of 12 IQMs. Among this final set, DDDs per 100(0) patient-days and days of therapy per patient-days were most frequently found in the review. The panel recommended that antibiotic use should be expressed in at least two metrics simultaneously. Conclusions: Our consensus procedure identified a set of IQMs that we propose as an evidence-based global standard.
How are trainees in clinical microbiology and infectious diseases supervised in Europe? An international cross-sectional questionnaire survey by the Trainee Association of ESCMID
(Springer, 2018-09-25) Palacios Baena, Zaira Raquel; Zapf, Thea Christine; Ong, David S.Y.; Maraolo, Alberto E.; Rönnberg, Caroline; Çimen, Cansu; Pulcini, Céline; Rodríguez-Baño, Jesús; Sanguinetti, Maurizio; Medicina
The purpose of this study was to map the supervision of European trainees in clinical microbiology and infectious diseases during their training. An international cross-sectional questionnaire survey of 38 questions was distributed among trainees and recently graduated medical specialists from European countries. Descriptive analyses were performed on both the total group of respondents and regionally. In total, 393 respondents from 37 different countries were included. The median of overall satisfaction with the supervisor was 4 (interquartile range 3–4) on a Likert scale (range 1, not satisfied at all–5, completely satisfied). Overall, merely 34% of respondents received constructive feedback from their supervisor on a regularly basis, 36% could evaluate their own supervisor, and just 63% were evaluated on their skills using a written plan. Fifty-two percent did not receive the opportunity to do a part of the specialty training abroad and 63% received support from their supervisors to be involved in research projects or publishing papers. A considerable proportion of trainees, mainly in Southern and Eastern European regions, felt that they did not receive sufficient supervision. This information may be useful in the pursuit of harmonizing the quality of training, achieving a common curriculum, and identifying robust and objective criteria to coach and evaluate trainees in a proper way.
A step forward in the definition of antimicrobial stewardship indicators: Better measurements, better work
(Sociedad Española de Farmacia Hospitalaria, 2019-03) Retamar Gentil, Pilar; Rodríguez-Baño, Jesús; Medicina
The available evidence suggests that there is a causal association between the development of antimicrobial stewardship programs (AMS) and reductions in the incidence of infection and colonization by antibiotic-resistant bacteria1 . The description of indicators and their monitoring over time is a key pillar of these programs; without an initial assessment, it is impossible to establish the baseline situation, the priorities for action, or the effectiveness of interventions. In addition, in an increasing number of centres, AMSs form part of service management agreements with the centres’ management, and hospitals with health services, as in the PIRASOA program in Andalusia (Spain) or the VINCAT program in Catalonia (Spain). This means that the indicators are the best tool for assessing adherence with the agreed objectives. (excerpt)
EEG changes induced by dopamine replacement therapy in Parkinson’s disease with impulse control disorders
(Elsevier, 2025) Martín Rodríguez, Juan Francisco; Iglesias Camacho, Elena; Gómez-Campos, Francisco J.; Franco-Rosado, Pablo; Garrote-Espina, Lorena; Muñoz Delgado, Laura; Jesús, Silvia; Macías García, Daniel; Adarmes-Gómez, Astrid; Carrillo García, Fátima María; Mir Rivera, Pablo; Psicología Experimental; Medicina
Objectives Impulse control disorders (ICDs) are a common complication in Parkinson’s disease (PD) patients undergoing dopaminergic therapy. Although neurophysiological markers of ICDs have been identified, the effect of dopaminergic therapy on these markers is not fully understood. This study investigates the effect of dopaminergic therapy on EEG oscillatory activity in PD patients with and without ICDs. Methods A total of 26 PD patients—14 with ICDs (PD + ICD) and 12 healthy controls (HC)—participated. EEG recordings were obtained during regular dopamine therapy (ON) and after overnight withdrawal (OFF). Spectral analysis assessed group differences in EEG activity and the effect of dopaminergic treatment, while correlations between neurophysiological parameters and impulsivity were analysed. Results Results showed increased theta power (4–7.5 Hz) in the fronto-central regions of PD+ICD patients in the OFF state compared to healthy controls. In the ON state, PD+ICD patients showed increased frontal high beta (21–30 Hz) and central alpha (8–12 Hz) activity. Frontal beta activity correlated with impulsivity, independent of treatment dose. Conclusions PD + ICD patients show distinct neurophysiological profiles influenced by dopaminergic treatment, highlighting the modulatory effect of therapy on EEG patterns in these patients. Significance This study highlights the modulatory effect of dopaminergic therapy on EEG oscillatory patterns in PD patients with ICDs.
Association of Physical Exercise With Structural Brain Changes and Cognitive Decline in Patients With Early Parkinson Disease
(Wolters Kluwer, 2025) Díaz-Galván, Patricia; Franco-Rosado, Pablo; Silva Rodríguez, Jesús; Castro-Labrador, Sandra; Labrador-Espinosa, Miguel Á.; Muñoz Delgado, Laura; Grothe, Michel J.; Mir Rivera, Pablo; Psicología Experimental; Medicina; Ministerio de Ciencia e Innovación (MICIN). España; Instituto de Salud Carlos III; European Union (UE); Junta de Andalucía; Fundación Alicia Koplowitz
Background and Objectives Accumulating evidence suggests that physical activity is associated with a better clinical and cognitive course in Parkinson disease (PD), yet whether these effects are subserved by structural brain alterations are largely unexplored. The aim of this study was to investigate whether regular physical activity associates with a reduced longitudinal rate of neurodegeneration and slower cognitive decline in PD. Methods In this longitudinal, observational cohort study, we used data from the Parkinson's Progression Markers Initiative. We included patients with early PD who had serial assessments of regular physical activity, measured using the Physical Activity Scale for the Elderly, along with serial MRI scans from at least 2 time points over 4 years of follow-up. Regional cortical thickness and subcortical volumes were calculated using established procedures. We used multivariate linear mixed-effects models to analyze the effect of regular physical activity on the progression of MRI parameters over time. We further used mediation models with nonparametric bootstrap to test mediation effects of longitudinal structural brain changes on the association between regular physical activity and longitudinal cognitive functioning. Results A total of 120 patients with early PD were included (mean [SD] age = 60.8 [9.3] years; 33% women). Average regular physical activity levels over time were significantly associated with slower cortical thinning in temporoparietal cortical regions, including the lateral temporal cortex, the fusiform gyrus, the parahippocampal gyrus, and the inferior parietal cortex (p < 0.05). Regular physical activity levels over time were also associated with slower volume loss in the hippocampus and the amygdala (p < 0.05). The association of regular physical activity with slower decline in memory and attention functions was mediated by slower decreases in temporoparietal cortical thickness (βPASE-HVLT, = 0.06, p = 0.050; βPASE-SDMT = 0.04, p = 0.017) and hippocampal volume (βPASE-SDMT = 0.03, p = 0.016). Discussion Regular physical activity is associated with a slower rate of neurodegeneration in the temporoparietal cortex and limbic areas in PD, which contributes to preserved cognitive function and improved long-term outcomes. This supports regular physical activity as a key intervention to delay disease progression and improve quality of life in patients with PD.
Impact of Initial Antifungal Therapy on the Outcome of Patients With Candidemia and Septic Shock Admitted to Medical Wards: A Propensity Score–Adjusted Analysis
(Oxford University Press, 2019-07-16) Falcone, Marco; Tiseo, Giusy; Gutiérrez Gutiérrez, Belén; Raponi, Giammarco; Carfagna, Paolo; Rosin, Chiara; Luzzati, Roberto; Rose, Diego Delle; Andreoni, Massimo; Farcomeni, Alessio; Venditti, Mario; Rodríguez-Baño, Jesús; Menichetti, Francesco; Medicina
Background: Echinocandins are recommended as firstline therapy in patients with candidemia. However, there is debate on their efficacy in survival outcomes. The aim of this study is to evaluate whether the choice of initial antifungal therapy improves mortality in patients with candidemia in relation to the presence of septic shock. Methods: Patients with candidemia hospitalized in internal medicine wards of 5 tertiary care centers were included in the study (December 2012–December 2014). Patient characteristics, therapeutic interventions, and outcome were reviewed. Propensity score (PS) was used as a covariate of the multivariate analysis to perform a stratified analysis according to PS quartiles and to match patients receiving “echinocandins” or “azoles.” Results: Overall, 439 patients with candidemia were included in the study. A total of 172 (39.2%) patients had septic shock. Thirty-day mortality was significantly higher in patients with septic shock (45.3%) compared with those without septic shock (31.5%; P = .003). Among patients with septic shock, the use of echinocandins in the first 48 hours, compared with azoles, did not affect 30-day mortality in the PS-adjusted Cox regression analysis (hazard ratio [HR], 0.77; 95% confidence interval [CI], 0.37–1.59; P = .48), the PS-stratified analysis, or the logistic regression model in matched cohorts (adjusted HR, 0.92; 95% CI, 0.51–1.63; P = .77). Conclusions: Echinocandin therapy seems not to improve the outcome of non–intensive care unit patients with septic shock due to candidemia. These findings support the urgent need of further studies in this patient population.
Impact of infectious diseases consultation on the outcome of patients with bacteraemia
(SAGE Publications, 2019-12-06) Jiménez Aguilar, Patricia; López-Cortés, Luis E.; Rodríguez-Baño, Jesús; Medicina; European Union (UE); Gobierno de España; Instituto de Salud Carlos III
Bacteraemia or bloodstream infections (BSI) are associated with much morbidity and mortality. Management of patients with bacteraemia is complex, and the increase in immunosuppressed patients and multidrug-resistant organisms poses additional challenges. The objective of this review is to assess the available published information about the impact of different aspects of management on the outcome of patients with BSI, and, specifically, the importance of infectious diseases specialists (IDS) consultation. The impact of management by IDS on different aspects, including interpretation of newer rapid techniques, early evaluation and treatment, and follow up, are reviewed. Overall, the available data suggest that IDS intervention improves the management and outcome of patients with BSI, either through consultation or structured unsolicited interventions in the context of multidisciplinary bacteraemia programmes.
Impact of antibiotic resistance on outcomes of neutropenic cancer patients with Pseudomonas aeruginosa bacteraemia (IRONIC study): study protocol of a retrospective multicentre international study
(BMJ Publishing Group, 2019-05-24) Albasanz Puig, Adaia; Gudiol, Carlota; Parody, Rocío; Tebe, Cristian; Akova, Murat; Araos, Rafael; Rodríguez-Baño, Jesús; IRONIC study group; Medicina; European Union (UE); Gobierno de España; Instituto de Salud Carlos III
Introduction: Pseudomonas aeruginosa (PA) has historically been one of the major causes of severe sepsis and death among neutropenic cancer patients. There has been a recent increase of multidrug-resistant PA (MDRPA) isolates that may determine a worse prognosis, particularly in immunosuppressed patients. The aim of this study is to establish the impact of antibiotic resistance on the outcome of neutropenic onco-haematological patients with PA bacteraemia, and to identify the risk factors for MDRPA bacteraemia and mortality. Methods and analysis: This is a retrospective, observational, multicentre, international study. All episodes of PA bacteraemia occurring in neutropenic onco-haematological patients followed up at the participating centres from 1 January 2006 to 31 May 2018 will be retrospectively reviewed. The primary end point will be overall case-fatality rate within 30 days of onset of PA bacteraemia. The secondary end points will be to describe the following: the incidence and risk factors for multidrug-resistant and extremely drug-resistant PA bacteraemia (by comparing the episodes due to susceptible PA with those produced by MDRPA), the efficacy of ceftolozane/tazobactam, the rates of persistent bacteraemia and bacteraemia relapse and the risk factors for very early (48 hours), early (7 days) and overall (30 days) case-fatality rates. Ethics and dissemination: The Clinical Research Ethics Committee of Bellvitge University Hospital approved the protocol of the study at the primary site. To protect personal privacy, identifying information of each patient in the electronic database will be encrypted. The processing of the patients’ personal data collected in the study will comply with the Spanish Data Protection Act of 1998 and with the European Directive on the privacy of data. All data collected, stored and processed will be anonymised. Results will be reported at conferences and in peer-reviewed publications.
ESCMID-EUCIC clinical guidelines on decolonization of multidrug-resistant Gram-negative bacteria carriers
(Elsevier, 2019-07) Tacconelli, Evelina; Mazzaferri, Fulvia; de Smet, A.M.; Bragantini, D.; Eggimann, P.; Huttner, B.D.; Rodríguez-Baño, Jesús; Medicina; European Union (UE); Gobierno de España; Instituto de Salud Carlos III
Scope: The aim of these guidelines is to provide recommendations for decolonizing regimens targeting multidrug-resistant Gram-negative bacteria (MDR-GNB) carriers in all settings. Methods: These evidence-based guidelines were produced after a systematic review of published studies on decolonization interventions targeting the following MDR-GNB: third-generation cephalosporin-resistant Enterobacteriaceae (3GCephRE), carbapenem-resistant Enterobacteriaceae (CRE), aminoglycoside-resistant Enterobacteriaceae (AGRE), fluoroquinolone-resistant Enterobacteriaceae (FQRE), extremely drug-resistant Pseudomonas aeruginosa (XDRPA), carbapenem-resistant Acinetobacter baumannii (CRAB), cotrimoxazole-resistant Stenotrophomonas maltophilia (CRSM), colistin-resistant Gram-negative organisms (CoRGNB), and pan-drug-resistant Gram-negative organisms (PDRGNB). The recommendations are grouped by MDR-GNB species. Faecal microbiota transplantation has been discussed separately. Four types of outcomes were evaluated for each target MDR-GNB:(a) microbiological outcomes (carriage and eradication rates) at treatment end and at specific post-treatment time-points; (b) clinical outcomes (attributable and all-cause mortality and infection incidence) at the same time-points and length of hospital stay; (c) epidemiological outcomes (acquisition incidence, transmission and outbreaks); and (d) adverse events of decolonization (including resistance development). The level of evidence for and strength of each recommendation were defined according to the GRADE approach. Consensus of a multidisciplinary expert panel was reached through a nominal-group technique for the final list of recommendations. Recommendations: The panel does not recommend routine decolonization of 3GCephRE and CRE carriers. Evidence is currently insufficient to provide recommendations for or against any intervention in patients colonized with AGRE, CoRGNB, CRAB, CRSM, FQRE, PDRGNB and XDRPA. On the basis of the limited evidence of increased risk of CRE infections in immunocompromised carriers, the panel suggests designing high-quality prospective clinical studies to assess the risk of CRE infections in immunocompromised patients. These trials should include monitoring of development of resistance to decolonizing agents during treatment using stool cultures and antimicrobial susceptibility results according to the EUCAST clinical breakpoints.
Analysis of the challenges in implementing guidelines to prevent the spread of multidrug-resistant gram-negatives in Europe
(BMJ Publishing Group, 2019-05-19) Tacconelli, Evelina; Buhl, Michael; Humphreys, Hilary; Malek, Veronika; Presterl, Elisabeth; Rodríguez-Baño, Jesús; Vos, Margreet; Zingg, Walter; Mutters, Nico Tom; EUCIC StopNegative group; Medicina; Baden-Württemberg Ministry of Science; ESCMIDs European Committee on Infection Control
Objective: The main objective of the study was to investigate major differences among European countries in implementing infection prevention and control (IPC) measures and reasons for reduced compliance. Design: An online survey including experts in IPC and a gap analysis were conducted to identify major limitations in implementing IPC guidelines. Setting: Europe. Main outcome measures: Four areas were targeted: (1) healthcare structure, (2) finances, (3) culture and (4) education and awareness. Perceived compliance to IPC measures was classified as low (<50%), medium (50% to 80%) and high (>80%). Countries were classified in three regions: North-Western Europe (NWE), Eastern Europe (EE) and Southern Europe (SE). Results: In total, 482 respondents from 34 out of 44 (77.3%) European countries participated. Respondents reported availability of national guidelines to control multidrug-resistant Gram-negatives (MDR-GN) in 20 countries (58.0%). According to participants, compliance with IPC measures ranged from 17.8% (screening at discharge) to 96.0% (contact precautions). Overall, three areas were identified as critical for the compliance rate: (1) number of infection control staff, (2) IPC dedicated educational programmes and (3) number of clinical staff. Analysis of reasons for low compliance showed high heterogeneity among countries: participants from NWE and SE deemed the lack of educational programmes as the most important, while those from EE considered structural reasons, such as insufficient single bed rooms or lacking materials for isolation, as main contributors to the low compliance. Conclusions: Although national guidelines to reduce the spread of MDR-GN are reported in the majority of the European countries, low compliance with IPC measures was commonly reported. Reasons for the low compliance are multifactorial and vary from region to region. Cross-country actions to reduce the spread of MDR-GN have to consider structural and cultural differences in countries. Locally calibrated interventions may be fruitful in the future.
Quasiexperimental intervention study protocol to optimise the use of new antibiotics in Spain: the NEW_SAFE project
(BMJ Publishing Group, 2020-07) Palacios Baena, Zaira Raquel; Valiente de Santis, Lucia; Maldonado, Natalia; Rosso Fernández, Clara María; Borreguero Borreguero, Irene; Herrero-Rodríguez, Carmen; Rodríguez-Baño, Jesús; Retamar Gentil, Pilar; Medicina; Junta de Andalucía; European Union; Instituto de Salud Carlos III; Gobierno de España
Introduction: Ceftaroline, tedizolid, dalbavancin, ceftazidime-avibactam and ceftolozane-tazobactam are novel antibiotics used to treat infections caused by multidrug-resistant pathogens (MDR). Their use should be supervised and monitored as part of an antimicrobial stewardship programme (ASP). Appropriate use of the new antibiotics will be improved by including consensual indications for their use in local antibiotic guidelines, together with educational interventions providing advice to prescribers to ensure that the recommendations are clearly understood. Methods and analysis: This study will be implemented in two phases. First, a preliminary historical cohort (2017–2019) of patients from 13 Andalusian hospitals treated with novel antibiotics will be analysed. Second, a quasiexperimental intervention study will be developed with an interrupted time-series analysis (2020–2021). The intervention will consist of an educational interview between prescribers and ASP leaders at each hospital to reinforce the proper use of novel antibiotics. The educational intervention will be based on a consensus guideline designed and disseminated by leaders after the retrospective cohort data have been analysed. The outcomes will be acceptance of the intervention and appropriateness of prescription. Incidence of infection and colonisation with MDR organisms as well as incidence of Clostridioides difficile infection will also be analysed. Changes in prescription quality between periods and the safety profile of the antibiotics in terms of mortality rate and readmissions will also be measured. Ethics and dissemination: Ethical approval will be obtained from the Andalusian Coordinating Institutional Review Board. The study is being conducted in compliance with the protocol and regulatory requirements consistent with International Council of Harmonisation E6 Good Clinical Practice and the ethical principles of the latest version of the Declaration of Helsinki. The results will be published in peer-reviewed journals and disseminated at national and international conferences.
Efficacy and safety of early treatment with sarilumab in hospitalised adults with COVID-19 presenting cytokine release syndrome (SARICOR STUDY): protocol of a phase II, open-label, randomised, multicentre, controlled clinical trial
(BMJ Publishing Group, 2020-11-14) León López, Rafael; Fernández, Sheila Cárcel; Limia Pérez, Laura; Romero Palacios, Alberto; Fernández-Roldán, María Concepción; Aguilar Alonso, Eduardo; Rodríguez-Baño, Jesús; Merchante Gutiérrez, Nicolás; Torre-Cisneros, Julián; Medicina; Junta de Andalucía; Gobierno de España; Instituto de Salud Carlos III
Introduction: About 25% of patients with COVID-19 develop acute respiratory distress syndrome (ARDS) associated with a high release of pro-inflammatory cytokines such as interleukin-6 (IL-6). The aim of the SARICOR study is to demonstrate that early administration of sarilumab (an IL-6 receptor inhibitor) in hospitalised patients with COVID-19, pulmonary infiltrates and a high IL-6 or D-dimer serum level could reduce the progression of ARDS requiring high-flow nasal oxygen or mechanical ventilation (non-invasive or invasive). Methods and analysis: Phase II, open-label, randomised, multicentre, controlled clinical trial to study the efficacy and safety of the administration of two doses of sarilumab (200 and 400 mg) plus best available therapy (BAT) in hospitalised adults with COVID-19 presenting cytokine release syndrome. This strategy will be compared with a BAT control group. The efficacy and safety will be monitored up to 28 days postadministration. A total of 120 patients will be recruited (40 patients in each arm). Ethics and dissemination: The clinical trial has been approved by the Research Ethics Committee of the coordinating centre and authorised by the Spanish Agency of Medicines and Medical Products. If the hypothesis is verified, the dissemination of the results could change clinical practice by increasing early administration of sarilumab in adult patients with COVID-19 presenting cytokine release syndrome, thus reducing intensive care unit admissions.
Risk Factors and Predictive Score for Bacteremic Biliary Tract Infections Due to Enterococcus faecalis and Enterococcus faecium: a Multicenter Cohort Study from the PROBAC Project
(American Society for Microbiology, 2022-06-30) Mussa, Marco; Martínez Pérez-Crespo, Pedro María; López-Cortés, Luis E.; Retamar Gentil, Pilar; Sousa Domínguez, Adrián; Goikoetxea Aguirre, Ane Josune; Rodríguez-Baño, Jesús; Corzo Delgado, Juan Enrique; Medicina; European Union; Gobierno de España; Instituto de Salud Carlos III
Biliary-tract bloodstream infections (BT-BSI) caused by Enterococcus faecalis and E. faecium are associated with inappropriate empirical treatment and worse outcomes compared to other etiologies. The objective of this study was to investigate the risk factors for enterococcal BT-BSI. Patients with BT-BSI from the PROBAC cohort, including consecutive patients with BSI in 26 Spanish hospitals between October 2016 and March 2017, were selected; episodes caused by E. faecalis or E. faecium and other causes were compared. Independent predictors for enterococci were identified by logistic regression, and a predictive score was developed. Eight hundred fifty episodes of BT-BSI were included; 73 (8.5%) were due to target Enterococcus spp. (48 [66%] were E. faecium and 25 [34%] E. faecalis). By multivariate analysis, the variables independently associated with Enterococcus spp. were (OR; 95% confidence interval): cholangiocarcinoma (4.48;1.32 to 15.25), hospital acquisition (3.58;2.11 to 6.07), use of carbapenems in the previous month (3.35;1.45 to 7.78), biliary prosthesis (2.19;1.24 to 3.90), and moderate or severe chronic kidney disease (1.55;1.07 to 2.26). The AUC of the model was 0.74 [95% CI0.67 to 0.80]. A score was developed, with 7, 6, 5, 4, and 2 points for these variables, respectively, with a negative predictive value of 95% for a score ≤ 6. A model, including cholangiocarcinoma, biliary prosthesis, hospital acquisition, previous carbapenems, and chronic kidney disease showed moderate prediction ability for enterococcal BT-BSI. Although the score will need to be validated, this information may be useful for deciding empirical therapy in biliary tract infections when bacteremia is suspected. IMPORTANCE Biliary tract infections are frequent, and a significant cause of morbidity and mortality. Bacteremia is common in these infections, particularly in the elderly and patients with cancer. Inappropriate empirical treatment has been associated with increased risk of mortality in bacteremic cholangitis, and the probability of receiving inactive empirical treatment is higher in episodes caused by enterococci. This is because many of the antimicrobial agents recommended in guidelines for biliary tract infections lack activity against these organisms. To the best of our knowledge, this is the first study analyzing the predictive factors for enterococcal BT-BSI and deriving a predictive score.
Correction to: Early Stepdown From Echinocandin to Fluconazole Treatment in Candidemia: A Post Hoc Analysis of Three Cohort Studies
(Oxford University Press, 2022-05-23) Moreno-García, E.; Puerta-Alcalde, Pedro; Gariup, G.; Fernández-Ruiz, M.; López-Cortés, Luis E.; Cuervo, G.; Garnacho Montero, José; Rodríguez-Baño, Jesús; García-Vidal, C.; Medicina; European Union (UE); Gobierno de España; Instituto de Salud Carlos III
There are no clear criteria for antifungal de-escalation after initial empirical treatments. We hypothesized that early de-escalation (ED) (within 5 days) to fluconazole is safe in fluconazole-susceptible candidemia with controlled source of infection. (excerpt from the original text)
Sepsis, a call for inclusion in the work plan of the European Center for Disease Prevention and Control
(Springer, 2023-08-24) Giamarellos-Bourboulis, Evangelos J.; Zinkernagel, Annelies S.; De Robertis, Edoardo; Azoulay, Élie; De Luca, Daniele; Rodríguez-Baño, Jesús; European Society for Pediatric and Neonatal Intensive Care (ESPNIC); Medicina; Hellenic Institute for the Study of Sepsis
Sepsis is a devastating condition resulting from our bodies’ dysregulated immune system response to infections, which can lead to organ failure, death, or sometimes life-long disability. (section)
Revisiting the personal protective equipment components of transmission-based precautions for the prevention of COVID-19 and other respiratory virus infections in healthcare
(European Centre for Disease Prevention and Control, 2023-08-10) Plachouras, Diamantis; Kacelnik, Oliver; Rodríguez-Baño, Jesús; Birgand, Gabriel; Borg, Michael A.; Kristensen, Brian; Monnet, Dominique L.; Medicina
Standard and transmission-based precautions are essential elements of infection prevention and control (IPC) practices. Transmission-based precautions are applied in addition to standard precautions in patients suspected or confirmed to be infected or colonised with certain microorganisms. There are three types of transmission-based precautions, depending on the transmission route: contact, droplet and airborne precautions. Each type of precautions has implications for the use of personal protective equipment (PPE) and for administrative and engineering control measures such as the placement of the patient, staff cohorting and training and environmental cleaning. Contact precautions include the application of gloves and gowns, droplet precautions require the use of medical face masks, and airborne precautions require the placement of the patient in an airborne precaution isolation room and the use of a well-fitted respirator by the staff. Sometimes, transmission-based precautions are combined to ensure that multiple modes of transmission are addressed. For respiratory infections, two concepts of transmission through the air have been distinguished: short-range droplet transmission and long-range aerosol transmission. In the current transmission-based precautions, most respiratory viruses were considered as being transmitted primarily through large droplets and only in exceptional situations by aerosols, resulting in the widespread application of droplet precautions such as the use of a medical face masks, rather than precautions against airborne transmission. The COVID-19 pandemic highlighted a potential limitation of the underpinning theory and application of transmission-based precautions as used during the past decades.
Predictors of clinical evolution of SARS-CoV-2 infection in hematological patients: A systematic review and meta-analysis
(Wiley, 2022-10-13) Carrara, Elena; Razzaboni, Elisa; Azzini, Anna Maria; De Rui, Maria Elena; Pinho Guedes, Mariana Nunes; Gorska, Anna; Rodríguez-Baño, Jesús; Tacconelli, Evelina; Medicina; European Union
Main aim of this systematic review is to quantify the risk and identify predictors of clinical evolution of SARS-CoV-2 in hematological patients compared to different control populations. Two independent reviewers screened the literature assessing clinical outcomes of SARS-CoV-2 infection in adult patients with active hematological malignancies published up to June 2021. Primary outcome was COVID-19 related mortality, secondary outcomes were hospital and intensive-care admission, mechanical ventilation (MV), and thromboembolic events. Variables related to study setting, baseline patients' demographic, comorbidities, underlying hematological disease, ongoing chemotherapy, COVID-19 presentation, and treatments were extracted. A total of 67 studies including 10,061 hematological patients and 111,143 controls were included. Most of the studies were retrospective cohorts (51 studies, 76%) and only 19 (13%) provided data for a control group. A significant increased risk of clinical progression in the hematological population compared to the controls was found in terms of COVID-19 related mortality (OR, 2.12; 95% CI, 1.77–2.54), hospitalization (OR, 1.98; 95% CI, 1.15–3.43), intensive-care admission (OR, 1.77; 95% CI, 1.38–2.26), and MV (OR, 2.17; 95% CI, 1.71–2.75). The risk remained significantly higher in the subgroup analysis comparing hematological patients versus solid cancer. Meta-regression analysis of uncontrolled studies showed that older age, male sex, and hypertension were significantly related to worse clinical outcomes of COVID-19 in hematological population. Older age and hypertension were found to be associated also to thromboembolic events. In conclusion, hematological patients have a higher risk of COVID-19 clinical progression compared to both the general population and to patients with solid cancer.
Incidence, associated disease burden and healthcare utilization due to Staphylococcus aureus prosthetic joint infection in European hospitals: the COMBACTE-NET ARTHR-IS multi-centre study
(Elsevier, 2023-10-04) Espíndola, Reinaldo; Vella, Venanzio; Benito, Natividad; Mur, Isabel; Tedeschi, Sara; Zamparini, Eleonora; Rodríguez-Baño, Jesús; Toro López, María Dolores del; Medicina; European Union (UE); Gobierno de España; Instituto de Salud Carlos III; Deutsche Forschungsgemeinschaft / German Research Foundation (DFG); Innovative Medicines Initiative Joint Undertaking
Background: The aim of this study was to estimate the incidence, associated disease burden and healthcare utilization due to Staphylococcus aureus prosthetic joint infections (SA-PJI) after primary hip and knee arthroplasty in European centres. Methods: This study was conducted in patients who underwent primary hip and knee arthroplasty in 19 European hospitals between 2014 and 2016. The global incidence of PJI and SA-PJI was calculated. The associated disease burden was measured indirectly as infection-related mortality plus loss of function. For healthcare utilization, number and duration of hospitalizations, number and type of surgical procedures, duration of antibiotic treatments, and number of outpatient visits were collected. Subgroup and regression analyses were used to evaluate the impact of SA-PJI on healthcare utilization, controlling for confounding variables. Results: The incidence of PJI caused by any micro-organism was 1.41%, and 0.40% for SA-PJI. Among SA-PJI, 20.7% were due to MRSA with substantial regional differences, and were more frequent in partial hip arthroplasty (PHA). Related deaths and loss of function occurred in 7.0% and 10.2% of SA-PJI cases, respectively, and were higher in patients with PHA. Compared with patients without PJI, patients with SA-PJI had a mean of 1.4 more readmissions, 25.1 more days of hospitalization, underwent 1.8 more surgical procedures, and had 5.4 more outpatient visits, controlling for confounding variables. Healthcare utilization was higher in patients who failed surgical treatment of SA-PJI. Conclusions: This study confirmed that the SA-PJI burden is high, especially in PHA, and provided a solid basis for planning interventions to prevent SA-PJI.
Implementation of a centralized pharmacovigilance system in academic pan-European clinical trials: Experience from EU-Response and conect4children consortia
(Wiley, 2023-01-21) Terzić, Vida; Levoyer, Léa; Figarella, Mélanie; Bigagli, Elisabetta; Mercier, Noémie; De Gastines, Lucie; Rodríguez-Baño, Jesús; c4c safety group; Medicina
Setting-up a high quality, compliant and efficient pharmacovigilance (PV) system in multi-country clinical trials can be more challenging for academic sponsors than for companies. To ensure the safety of all participants in academic studies and that the PV system fulfils all regulations, we set up a centralized PV system that allows sponsors to delegate work on PV. This initiative was put in practice by our Inserm-ANRS MIE PV department in two distinct multinational European consortia with 19 participating countries: conect4children (c4c) for paediatrics research and EU-Response for Covid-19 platform trials. The centralized PV system consists of some key procedures to harmonize the complex safety processes, creation of a local safety officer (LSO) network and centralization of all safety activities. The key procedures described the safety management plan for each trial and how tasks were shared and delegated between all stakeholders. Processing of serious adverse events (SAEs) in a unique database guaranteed the full control of the safety data and continuous evaluation of the risk–benefit ratio. The LSO network participated in efficient regulatory compliance across multiple countries. In total, there were 1312 SAEs in EU-Response and 83 SAEs in c4c in the four trials. We present here the lessons learnt from our experience in four clinical trials. We managed heterogeneous European local requirements and implemented efficient communication with all trial teams. Our approach builds capacity for PV that can be used by multiple academic sponsors.

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